MAUDE Adverse Event Report: WILLIAM A. COOK AUSTRALIA, PTY LTD ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number	ZFEN-P-2-32-109-R
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	12/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At the conclusion of the implant procedure, there was a leak seen in-between the two components.The device was implanted; at the final imaging run there was a big rush of a leak seen.It was thought to be either a type 3 or a type 4 endoleak.

• Brand Name: ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM A. COOK AUSTRALIA, PTY LTD; 95 brandl street; eight mile plains; brisbane 4113 ; AU 4113
• MDR Report Key: 23933522
• Report Number: 3005580113-2025-00078
• Device Sequence Number: 5611155
• Product Code: MIH
• UDI-Device Identifier: 10827002325392
• UDI-Public: (01)10827002325392(17)281030(10)AC1198628
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/08/2025
• Report Date (Section F): 12/31/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: ZFEN-P-2-32-109-R
• Device Lot Number: AC1198628
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/08/2025
• Device Age: 2 MO
• Date Report to Manufacturer: 12/12/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/31/2025
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Sex: Male
• Date Report Sent to FDA: 12/31/2025